Single Use Bioprocessing Parts and Components

The biotechnology industry might appear similar to pharmaceuticals, conflated through terms such as “biopharma,” but its products stem from a distinctly different origin. While both sectors can produce medicines, biotechnology expands into the research, development and production of commercial products for medical or agricultural purposes and even food and beverages.

Biotechnology products are derived from living organisms unlike pharmaceutical companies, which create products using chemical compounds and synthetic processes. The biotechnology industry encompasses multiple segments and has a massive market impact, with a projected CAGR (Compound Annual Growth Rate) above 12% through 2030.

Single-Use Bioprocessing Technologies Aid Scale-Up or Manufacturing

Single-use technologies (SUTs) were popular systems for biotech companies involved with process development, prototyping and benchtop scale-up. However, more firms have turned to SUTs for general manufacturing under cGMP guidelines. This is due to the multiple advantages of SUTs compared to stainless steel setups and semi-disposable systems.

A new stainless-steel system represents a hefty capital expenditure and requires an extended timeframe to set up and cap production capacity once installed. These units also need regular clean-in-place (CIP) sanitation cycles to clean the equipment. CIP cycles require enormous amounts of chemicals, water and the corresponding energy to propel this sanitation process—necessary when sterilizing reusable equipment. These sterilization procedures help companies adhere to federal regulations, prevent cross-contamination, clear out bacterial growth and preserve product quality and integrity.

SUTs eliminate the need for this intense dependency on CIP or COP (Clean Out of Place) procedures and the extensive outlay of associated precious resources. In addition, SUTs are economical, operationally efficient and minimize cross-contamination risks, with each product flow path designed for one-time or limited use.

Single-use systems place fewer demands on the utilities and related expenses than legacy systems. These offer flexible design configurations for stacking or relocation and occupy a more minimal footprint, a valuable feature for start-ups and established operations alike to optimize available processing space.

While challenges in implementing SUTs remain, including the stringent regulations governing the use of disposable systems within the bioprocessing segment, it helps to work with a business partner that understands and can meet these industry standards.